A randomized, phase 3 multicenter clinical trial to confirm the clinical efficacy and evaluate the safety of linaprazan glurate compared to lansoprazole in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cinclus Pharma Holding AB (publ)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

completed 19 May 2026

Decision date (initial)

2026-05-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Cinclus Pharma Holding AB

External identifiers

EU CT number

2025-522750-39-00

WHO UTN

U1111-1324-0039

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To confirm non-inferiority of linaprazan glurate ‘high dose’ compared to lansoprazole in the maintenance of healing of all grades of EE due to GERD after 24 weeks of maintenance treatment

Secondary objectives 8

1. 1. To confirm non-inferiority of linaprazan glurate ‘low dose’ compared to lansoprazole in the maintenance of healing of all grades of EE due to GERD after 24 weeks of maintenance treatment.
2. 2. To confirm superiority of linaprazan glurate ‘high dose’ compared to lansoprazole in the maintenance of healing of EE due to GERD of LA grades C/D after 24 weeks of maintenance treatment.
3. 3. To confirm superiority of linaprazan glurate ‘low dose’ compared to lansoprazole in the maintenance of healing of EE due to GERD of LA grades C/D after 24 weeks of maintenance treatment.
4. 4. To confirm superiority of linaprazan glurate ‘high dose’ compared to lansoprazole in the maintenance of healing of all grades of EE due to GERD after 24 weeks of maintenance treatment.
5. 5. To confirm superiority of linaprazan glurate ‘low dose’ compared to lansoprazole in the maintenance of healing of all grades of EE due to GERD after 24 weeks of maintenance treatment.
6. 6. • To confirm non-inferiority of linaprazan glurate ‘high dose’ compared to lansoprazole in participant-reported 24-hour heartburn-free days (%) after 24 weeks of maintenance treatment. • To confirm non-inferiority of linaprazan glurate ‘low dose’ compared to lansoprazole in participant-reported 24-hour heartburn-free days (%) after 24 weeks of maintenance treatment. • To confirm superiority of linaprazan glurate ‘high dose’ compared to lansoprazole in participant-reported 24-hour heartburnfree days (%) after 24 weeks of maintenance treatment. • To confirm superiority of linaprazan glurate ‘low dose’ compared to lansoprazole in participant-reported 24-hour heartburn-free days (%) after 24 weeks of maintenance treatment.
7. 7. To assess the healing rates of linaprazan glurate ‘high dose’ and ‘low dose’ compared to lansoprazole in the maintenance of healing of EE due to GERD after 52 weeks of maintenance treatment.
8. 8. To evaluate the safety and tolerability of linaprazan glurate ‘high dose’ and ‘low dose’ compared to lansoprazole throughout maintenance treatment.

Conditions and MedDRA coding

Erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. An individual who has participated in a preceding linaprazan glurate healing trial will be asked to participate in this trial if the following criteria apply: 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures.
2. 2. The participant has a healed EE as assessed by central review of endoscopic examination either from the last regular visit in a preceding phase 3 healing trial OR from the Run-in Period to the present maintenance trial.
3. 3. The participant is willing and able to comply with all aspects of the protocol (including endoscopies, tablet and capsule swallowing, electronic device [e-device] completion, etc.).

Exclusion criteria 15

1. An individual who has participated in a preceding linaprazan glurate phase 3 healing trial can be enrolled in this maintenance trial unless they meet any of the following exclusion criteria: 1. EE as graded from the endoscopy during the Run-in Period (only applicable for participants with previous endoscopy >14 days before the last regular visit in the preceding healing trial).
2. 2. Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett’s esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture.
3. 3. Significant noncompliance with protocol-specified procedures or treatment in the preceding healing trial as judged by the Investigator.
4. 4. Adverse event (AE) resulting in premature discontinuation of IP in the preceding healing trial.
5. 5. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the trial results or the participant’s ability to participate in the trial. The following examples are conditions that would exclude the participant from participating: a. History of myocardial infarction/ acute coronary syndrome within 3 months prior to the M0 visit b. History of ventricular arrhythmia or implanted cardioverter defibrillator c. Symptomatic congestive heart failure (New York Heart Association [NYHA] class 3-4) d. Family history of/ diagnosis of hereditary arrhythmia syndrome
6. 6. History of adult asthma that required intensive treatment in an emergency room
7. 7. Any planned major surgery within 52 weeks of the Run-in Period.
8. 8. Any clinically significant laboratory parameter outside reference value that has occurred since Screening or Baseline values in the preceding healing trial and which, in the opinion of the Investigator, may suggest a new or insufficiently understood disease, may present an unreasonable risk to the participant as a result of his/her participation in the trial, or may interfere with trial assessments. The below laboratory test results during the Run-in Period* (HX/M0 visit) are exclusionary: a. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN) for the central laboratory conducting the test. b. Serum total bilirubin (TBL) >1.5 × ULN for the central laboratory conducting the test. (individuals with Gilbert’s syndrome can be included). *Note: One retest is allowed during the Run-in Period.
9. 9. Enrollment in another interventional clinical trial, except for ongoing participation in an EE healing trial with linaprazan glurate.
10. 10. Current or history of alcohol, drug abuse, and/or use of androgens/anabolic steroids (testosterone and testosterone esters [enanthate, undecanoate, cypionate], methyltestosterone, oxandrolone, stanozolol, fluoxymesterone, danazol, tetrahydrogestrinone, 7α-methyl-19-nortestosterone) within 2 years prior to Run-in Period. Stable androgen substitution treatment for male hypogonadism is allowed.
11. 11. Women who are pregnant or breast feeding
12. 12. Individual is an employee of the Investigator, trial site, Sponsor, or Contract Research Organization (CRO) with direct involvement in the proposed trial or other trials under the direction of that Investigator, trial site, Sponsor, or CRO, as well as family members of the employee of the Investigator, trial site, Sponsor, or CRO.
13. 13. Individuals who have previously participated (completed or withdrawn) in this trial.
14. 14. A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner and who is unwilling to routinely use highly effective contraception from the signing of the ICF until 7 days after the last dose of IP.
15. 15. A male participant with a partner of childbearing potential who is unwilling to routinely use highly effective contraception and is unwilling to agree to not father a child from the signing of the ICF until at least 7 days after the last dose of IP.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1.Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.

Secondary endpoints 5

1. 1. Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy
2. 2. Maintained healing from EE as assessed by central reading of endoscopy after 24 weeks in participants with Baseline EE due to GERD of LA grades C/D.
3. 3. Percentage of heartburn-free days from Baseline to Week 24 based on electronic Diary
4. 4. Maintained healing of EE comparing linaprazan glurate ‘high dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy.
5. 5. Maintained healing of EE comparing linaprazan glurate ‘low dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 2

Placebo 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cinclus Pharma Holding AB (publ)

Sponsor organisation

Cinclus Pharma Holding AB (publ)

Address

Kungsbron 1 Plan 3 Trappa G

City

Stockholm

Postcode

111 22

Country

Sweden

Scientific contact point

Organisation

Cinclus Pharma Holding AB (publ)

Contact name

Rikard Reneland

Public contact point

Organisation

Cinclus Pharma Holding AB (publ)

Contact name

Rikard Reneland

Third parties 1

Locations

6 EU/EEA countries · 70 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 60 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications